Since the change in legislation in 2018 allowing “cannabis-based products for medicinal use” (CBPMs) to be prescribed in the UK, we have seen significant developments in the industry. As the number of patients being prescribed CBPMs grows, the demand for a greater variety of products also increases.
So how can you meet that demand and launch new CBPMs into the UK market?
The truth is this is a complex process involving multiple stakeholders, regulatory and quality hurdles, and risk of delays along the way. With a solid plan and the right expertise, this is very much an achievable goal!
Here are 10 key points to get you started.
1. Are you ready? As an importer, ensure you have the appropriate licenses in place (WDA(h)/MS) to bring CBPMs into the UK. A storage facility that is equipped to hold Schedule 2 controlled drugs (finished, unlicensed CBPMs medicinal cannabis) must be in place and ensure this is maintained to the conditions required. Note that a Schedule 1 category is required for API (Active Pharmaceutical Ingredient/bulk medicinal cannabis).
2. Source your supplier – In most cases, CBPM suppliers will be based outside the UK, either a listed country (EU 27 member states) or the rest of the world. Ensure all appropriate due diligence is conducted. Medicinal cannabis must be cultivated to GACP standards and manufactured in EU Good Manufacturing Practice (GMP) licensed sites, or equivalent, recognized regulatory body i.e. Canada.
3. Select your products – Assess the market and determine patient demand and any gaps. Speak to your supplier and see what is available in their portfolio. Remember consistency is key! Cannabis is a plant and natural variation is common so aim to find products that have been grown consistently across multiple batches with Quality Control (QC) testing results to evidence this.
4. Finalise your product – Once you have selected your products determine the strength of your active ingredients i.e. the THC and CBD values, product formulations, pack sizes etc. Different products specifications are used for different disease conditions.
5. Create your documentation – Ensure all relevant documents in your Quality Management System (QMS) are updated to include your new products. The product specification is a key reference document which contains all the important details, so accuracy is critical!
6. Register with the Home Office National Drugs control System (NDS) – This is a necessary step to obtain import licenses. Ensure you register your supplier’s establishment and preparations into the system.
7. Obtain clinical justifications – As CBPMs are an unlicensed medicine, a clinical justification is required to prescribe. This must be obtained from a physician on the GMC specialist register. The justification is an MHRA requirement to import CBPMs into the UK.
8. Obtain an MHRA Letter of No Objection to Import – To import unlicensed medicines, you must complete the Notification of Import process and submit it to the Imports team at the Medicines and Healthcare products Regulatory Agency (MHRA). They will review your submission; assess all supplier and product documentation you provide for accuracy and if satisfied will issue a Letter of No Objection to Import.
9. Apply for your Import License – You can now go back into the NDS portal and apply for an import license with the Letter of No Objection to Import that you have obtained from the MHRA.
10. Commence the import process – Once you have obtained your license you can liaise with your supplier to bring the CBPMs into the UK.
The above is by no means an exhaustive list.
There are many other details you will need to consider along the way, but this should provide you with a flavour of what is involved.
Canna Strategy can support you with product registration, and licensing you for the import, storage and distribution of CBPM.
Contact us for a no obligation discussion.